Adding L-Carnitine to Clomiphene Citrate for Induction of Ovulation in Women With Polycystic Ovary Syndrome

Phase 4

Completed

• Conditions: Polycystic Ovary Syndrome
• Interventions: Drug: Clomiphene Citrate 50mg; Drug: Placebo Oral Tablet; Drug: L-carnitine

• Registration Number: NCT03630341
• Lead Sponsor: Assiut University

Brief Summary

Polycystic ovary syndrome is one of the most common endocrine disorders, affecting about 6-10% of women in their reproductive age. Anovulation and hyperandrogenism are often present together with hyperinsulinaemia and insulin resistance

Detailed Description

Not available

Study Timeline

• Study Start: 2016-02-01
• Primary Completion: 2018-03-31
• Study Completion: 2018-05
• Status Verified: 2018-08
• Study First Submitted: 2018-08-04
• Study First Submitted QC: 2018-08-10
• Last Update Submitted: 2018-08-10
• Study First Posted: 2018-08-14
• Last Update Posted: 2018-08-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 150

Inclusion Criteria

• Primary or secondary infertility.
• Normal Hysterosalpingo-graphy
• Normal Semen analysis of the husband.

Exclusion Criteria

• Patient's refusal.
• Male factors of infertility and/or abnormal Hysterosalpingo-graphy
• Hyperprolactinemia (prolactin ≥ 22 ng/dl).
• FSH on day 3 > 15 mIU/mL.
• Gross ovarian pathology diagnosed by ultrasound.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
control group	Placebo Oral Tablet	This group will receive oral clomiphene citrate 50 mg tablet, two times per day from the third day of the cycle until the seventh day of the cycle plus oral placebo tablet, three times per day from the third day until the day of the pregnancy test.
study group	L-carnitine	This group will receive oral clomiphene citrate 50 mg tablet, two times per day from the third day of the cycle until the seventh day of the cycle plus oral carnitine 1g tablet, three times per day from the third day until the day of the pregnancy test.
study group	Clomiphene Citrate 50mg	This group will receive oral clomiphene citrate 50 mg tablet, two times per day from the third day of the cycle until the seventh day of the cycle plus oral carnitine 1g tablet, three times per day from the third day until the day of the pregnancy test.
control group	Clomiphene Citrate 50mg	This group will receive oral clomiphene citrate 50 mg tablet, two times per day from the third day of the cycle until the seventh day of the cycle plus oral placebo tablet, three times per day from the third day until the day of the pregnancy test.

Primary Outcome Measures

Name	Time	Method
clinical pregnancy rate	1 month	visible intra-uterine gestational sac, with a positive fetal heart beat, viewed during a transvaginal ultrasound (when the b-hCG concentration was more than 1500 IU/l)